FDA.reportPublic FDA data

Life Warmer Quantum Charger

Primary DI
00868058000430
Brand
Life Warmer Quantum Charger
Company
NORTH AMERICAN RESCUE, LLC
Model
63-5905
Catalog number
35-0002
Device description
The Lifewarmer Quantum Charger from is an AC-powered reusable device that can fully charge the Quantum Battery rapidly and safely. The Charger has built-in algorithms to ensure proper, steady charging without overcharging or damaging the health and integrity of the battery. The Battery can go from nearly 0% to full within 90 minutes. The Life Warmer Charger has two colored LED lights to inform the provider of the status of charge and condition of the battery.The Quantum Battery Charger connects to the Battery via an omni-directional plug that allows for rapid energy transfer while prioritizing safety even in cases of hasty disconnection. The Quantum Battery will alert the user if there is any issue associated with the health of the battery. The Charger comes supplied with a 6-foot AC power cord.
Published
2019-09-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
BSBWarmer, Blood, Non-Electromagnetic Radiation
LGZWarmer, Thermal, Infusion Fluid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSBWarmer, Blood, Non-Electromagnetic RadiationHematology2
LGZWarmer, Thermal, Infusion FluidGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181775000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181775000Quantum Blood and IV Fluid Infusion WarmerLife Warmer, Inc.2019-01-28LGZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00868058000430PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00868058000430008680580004308680580004300868058000430

GMDN Terms#

Term, Definition table
TermDefinition
Conduction blood/fluid warmerA mains electricity (AC-powered) device, which may include rechargeable batteries, designed for in-line heating of banked blood, blood products, intravenous (IV) solutions, and irrigation fluids, typically from about 4ºC to near body temperature (i.e., 35 to 37ºC) before infusion, through the conduction of heat. The device usually includes a surface heat exchanger (e.g., heated dry plate) for the conduction of heat to the infusion blood/fluid via a disposable set (e.g., tubing or pouch); it also includes temperature controls and/or alarms. It is typically mounted on an IV pole under the infusion bag; it does not infuse blood/fluid.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
832426782
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842209140367NAR85-523385-52332026-10-14
00842209140374NAR85-523485-52342026-10-14
00842209140381NAR85-524085-52402026-10-14
00842209140398NAR Kit88-005088-00502026-10-14
00842209140404NAR80-0097-TLS80-0097-TLS2026-10-14
00842209140411NAR80-198980-19892026-10-14
00842209140428NAR80-201580-20152026-10-14
00842209140435NAR85-392785-39272026-10-14
00842209140442NAR85-523685-52362026-10-14
00842209140459NAR85-524185-52412026-10-14
00842209140466NAR85-524585-52452026-10-14
00842209140473NAR80-0494A80-0494A2026-10-14
00842209140480NAR80-1091A80-1091A2026-10-14
00842209140497NAR80-0951A80-0951A2026-10-14
00842209140503NAR80-1166A80-1166A2026-10-14
00842209140510NAR80-1157A80-1157A2026-10-14
00842209140527NAR82-0058A82-0058A2026-10-14
00842209140534NAR82-0076A82-0076A2026-10-14
00842209140541NAR82-0051A82-0051A2026-10-14
00842209140558NAR82-0055A82-0055A2026-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B286DWC243074TGRMB1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-10-05
B286SWC243074MBST1Single Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-09-30
B286DWC183074TLG4B1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-09-18
B286DWC182464TG4B220C1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286DWC243064T4BR21Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286DWC243074TGLHMB1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286DWC243074TGMB220C1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286DWC243074TGMBAVT1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286DWC243074TMBAVT1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286DWC243074TMBEL220C1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286DWC243074TTS4B1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286SWC1518224B1Single Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286SWC151822LHNB1Single CHAMBER WARMING CABINETM.A.C. MEDICAL INC.LGZ2026-08-21
B286SWC242424GNB1Single CHAMBER WARMING CABINETM.A.C. MEDICAL INC.LGZ2026-08-21
B286DWC183074EG4BC1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC183074EGMB220C1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC183074T4BAVT1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC183074T4BR21Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC183074TGMB220C1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC183074TTS4B1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC242464T4B1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC242464TMB1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC242474EGMB220C1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC242474TG4BR21Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC242474TG4BR2SB1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286243074TGMB1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-17
B286SWC242464GMB1single Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-14
00841027105749Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2026-07-24
00841027105725Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2026-07-12
00841027104766Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2026-06-02